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Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

NCT06046222•NS Pharma, Inc.

View on ClinicalTrials.gov

Summary

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.

Detailed Description

The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study treatment period in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without Mepolizumab/Benralizumab therapy. During the treatment period corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to provide written informed consent prior to participation in the study.
•Male or female subjects aged ≥18 years at the time the informed consent form is signed.
•Diagnosis of EGPA: Subjects who have been diagnosed with EGPA based on the history or presence of eosinophilia plus at least a history or presence of 2 of additional features of EGPA.
•Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatment with Mepolizumab/Benralizumab.
•Use of adequate contraception.

Exclusion Criteria

•Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis
•Imminently life-threatening EGPA at the time of screening.
•History or presence of any form of cancer within 5 years prior to screening.
•Serious liver, renal, blood, or psychiatric disease
•Severe or clinically significant cardiovascular disease uncontrolled with standard treatment
•Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections)
•Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening.
•HIV positive status
•Active hepatitis due to hepatitis B virus or hepatitis C virus
•Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus)
+9 more criteria

Locations (34)

National Jewish Health

Denver, Colorado, United States

Mayo Clinic

Rochester, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Alberta

Edmonton, Alberta, Canada

St Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

University of Toronto

Toronto, Ontario, Canada

Key Dates

Start Date

December 20, 2023

Primary Completion Date

June 1, 2026

Completion Date

July 1, 2026

Last Updated

May 22, 2025

Enrollment

ESTIMATED participants

Conditions

Eosinophilic Granulomatosis With PolyangiitisChurg-Strauss Syndrome

Interventions

NS-229

DRUG

Placebo

DRUG

Contacts

NS Pharma, Inc.

CONTACT

1-866-677-4276 trialinfo@nspharma.com

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

NCT03004326

Cryoglobulinemic Vasculitis (CV)Drug-induced Vasculitis+8 more

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RECRUITINGPHASE2/PHASE3

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

NCT05979051

Eosinophilic Granulomatosis With Polyangiitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Inclusion Criteria

Exclusion Criteria

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)

NUCALA® Special Drug Use Investigation (EGPA, Long-term)

Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma